Concord Biotech completes USFDA inspection of Dholka API facility
Concord Biotech (BSE: CONCORDBIO) announced today the completion of the United States Food and Drug Administration (USFDA) inspection of its Active Pharmaceutical Ingredient (API) facility located in Dholka, India. The inspection took place between April 28, 2025, and May 2, 2025. The USFDA issued Form 483 with four observations at the conclusion of the inspection. Concord Biotech stated the observations are procedural in nature and not related to data integrity. The company plans to provide a detailed response to the USFDA within the required timeframe and is confident in addressing the observations expeditiously. The company has disclosed this information under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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